PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
FDA 510(k) clearance K930335 · decided 1994-02-01
Clearance details
- K-number
- K930335
- Device name
- PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
- Applicant
- Fittydent-Altwirth & Schmitt GmbH
- Decision
- Substantially Equivalent
- Date received
- 1993-01-22
- Decision date
- 1994-02-01
- Days to decision
- 375 days
- Clearance type
- Traditional
- Product code
- KOO
- Device class
- 1
- Regulation number
- 872.3490
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fittydent-Altwirth & Schmitt GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (K945200) | Procter & Gamble Co. | 1994-11-30 |
| ORAFIX SPECIAL DENTURE ADHESIVE (K943486) | Smithkline Beecham Corp. | 1994-11-03 |
| NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K862876) | Block Drug Company, Inc. | 1986-08-29 |
Recalls involving this device
No recalls on record reference this clearance.